CML, RelapsedNCT07517315
Expanded Access to Vodobatinib for Patients With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Not Responded to Previous Treatments
A study testing K0706 in people with CML, Relapsed and CML, Refractory, run by Sun Pharma Advanced Research Company Limited at 10 sites in 7 countries.
Trial summary
The main study (CLR_15_03) was terminated prematurely for non-safety reasons due to changes in the clinical treatment landscape and evolving regulatory considerations. To ensure continuity of care, post-trial access to vodobatinib was initiated in January 2024 for subjects who, in the judgment of their treating… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CML, Relapsed, CML, Refractory
- What is being tested?
- K0706
- How many people
- Not given
- Where
- 10 sitesin 7 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Subjects who previously received K0706 during the CLR_15_03 study.
- Absence of any alternative therapies for the management of CML.
- Willing and able to give written, and dated, informed consent.
- Willing and able to comply with the scheduled visits.
Who cannot join
- Presence of T315I.
Trial locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
United States2 sites
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
India2 sites
Meenakshi Mission Hospital and Research Centre
Madurai
Tata Memorial Centre, Advanced Centre for Treatment, Research and Education in Cancer
Navi Mumbai
Romania2 sites
Colentina Clinical Hospital
Bucharest
Oncology Institute "Prof. Dr. Ion Chiricuță"
Cluj-Napoca
Hungary1 site
University of Debrecen, Clinical Center Institute of Internal Medicine
Debrecen, 4032
Italy1 site
IRCCS Romagnolo Institute for the Study of Tumors "Dino Amadori"
Meldola, FC, 47014
About this study
The main study (CLR_15_03) was terminated prematurely for non-safety reasons due to changes in the clinical treatment landscape and evolving regulatory considerations. To ensure continuity of care, post-trial access to vodobatinib was initiated in January 2024 for subjects who, in the judgment of their treating investigator, continued to derive clinical benefit and had no viable alternative treatment options.
Continued treatment and all aspects of medical care are determined and managed solely by the Principal Investigator/treating physician in accordance with local standard of care. Responsibility of the medical care rests with the Investigator, as agreed with the Sponsor.
Between January 2024 and January 2025, 29 subjects transitioned to post-trial access in compliance with applicable country-specific guidelines.
- Conditions
- CML, Relapsed, CML, Refractory
- Being tested
- K0706
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K0706Drug
Also called Vodobatinib
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CML, RelapsedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517315
- Sponsor's protocol ID
- Expanded Access_CLR_15_03
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access to Vodobatinib for Patients With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Not Responded to Previous Treatments
- ClinicalTrials.gov ID
- NCT07517315
- Acronym / sponsor ID
- Expanded Access_CLR_15_03
- Conditions
- CML, Relapsed, CML, Refractory
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main study (CLR_15_03) was terminated prematurely for non-safety reasons due to changes in the clinical treatment landscape and evolving regulatory considerations. To ensure continuity of care, post-trial access to vodobatinib was initiated in January 2024 for subjects who, in the judgment of their treating investigator, continued to derive clinical benefit and had no viable alternative treatment options.
Continued treatment and all aspects of medical care are determined and managed solely by the Principal Investigator/treating physician in accordance with local standard of care. Responsibility of the medical care rests with the Investigator, as agreed with the Sponsor.
Between January 2024 and January 2025, 29 subjects transitioned to post-trial access in compliance with applicable country-specific guidelines.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who previously received K0706 during the CLR_15_03 study.
- Absence of any alternative therapies for the management of CML.
- Willing and able to give written, and dated, informed consent.
- Willing and able to comply with the scheduled visits.
Key exclusion criteria (1 listed)
- Presence of T315I.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K0706Also: Vodobatinib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing K0706 in people with CML, Relapsed and CML, Refractory, run by Sun Pharma Advanced Research Company Limited at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, India, Romania, France, Hungary and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.